Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

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Fachinformation Fachinformation (SPC)
12-06-2017

Wirkstoff:

Tiamulin hydrogen fumarate

Verfügbar ab:

Huvepharma NV

ATC-Code:

QJ01XQ01

INN (Internationale Bezeichnung):

Tiamulin hydrogen fumarate

Dosierung:

125 milligram(s)/millilitre

Darreichungsform:

Oral solution

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Pigs

Therapiebereich:

tiamulin

Anwendungsgebiete:

Antibacterial

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2010-02-05

Fachinformation

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmulin 125 mg/ml Oral
Solution for use in drinking water for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Tiamulin hydrogen fumarate
125 mg (equivalent to 101.2 mg tiamulin)
EXCIPIENTS
Methyl parahydroxybenzoate (E218)
0.90 mg
Propyl parahydroxybenzoate
0.10 mg
For the full list of excipients: see section 6.1
3 PHARMACEUTICAL FORM
Oral solution for use in drinking water.
Clear colourless to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In pigs
For the treatment of swine dysentery caused by or further complicated
by tiamulin-susceptible_ Brachyspira_
_hyodysenteriae._
For the treatment of enzootic pneumonia and the reduction of lesions
caused by tiamulin-susceptible_ Mycoplasma_
_hyopneumoniae._
The presence of the disease in the herd should be established before
use.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of the excipient.
Do not use in the case of resistance to tiamulin.
Do not administer products containing monensin, salinomycin, narasin,
maduramicin or other ionophores during or for
at least seven days before or after treatment with the product. See
also section 5.1. and 4.8.
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